Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder (OCDDRUG)

This study has been completed.
Sponsor:
Information provided by:
Osaka City University
ClinicalTrials.gov Identifier:
NCT00854919
First received: March 2, 2009
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

Objective: Although atypical antipsychotic drugs (AAPDs) have been found effective in the augmentation of serotonin reuptake inhibitors (SRIs) for treatment-resistant obsessive-compulsive disorder (OCD) in short terms trials, there are few data on the effectiveness and safety of these agents in clinical settings over the long term.

Method: Subjects (n=46) who responded to selective SRIs (SSRIs) in an initial 12-week trial were continued on SRI-monotherapy plus cognitive-behavioral therapy (CBT) for one year. Subjects (n=44) who failed to respond to SSRIs were randomly assigned to one of 3 AAPDs such as risperidone and were consecutively treated using SSRI+AAPD combined with CBT for a year.


Condition Intervention Phase
SSRI-Refractory Obsessive-Compulsive Disorder
Drug: atypical antipsychotic drug
Behavioral: exposure response prevention
Phase 4

Study Type: Interventional
Official Title: An Long Term Trial on Effectiveness and Safety of Atypical Antipsychotic Agents in Augmenting SSRI-Refractory Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by Osaka City University:

Primary Outcome Measures:
  • Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • yale-Brown Obsessive-Compulsive Scale [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • BMI, TG, T-CHO, FBS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT
All subjects received cognitive-behavioral therapy (CBT) during the study period.
Behavioral: exposure response prevention
After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.
Experimental: 1
Drug; Paroxetine (30-50mg/D)or Fluvoxamine (150-250mg/D), 1-year administration
Drug: atypical antipsychotic drug
For SSRI-refractory group, either atypical antipsychotic such as mean doses of RIS (3.1±1.9mg/day), of OLZ (5.1±3.2mg/day), and of QET (60.0±37.3mg/day) was added on ongoing SSRI(Paroxetine, Fluvoxamine).
Behavioral: exposure response prevention
After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.
Active Comparator: 2
Either risperidone (1-5mg/D), olanzapine (1-5mg/D) or quetiapine (25-100mg/D) was added to ongoing SSRI, the combination trial was continued at least for half a year.
Drug: atypical antipsychotic drug
For SSRI-refractory group, either atypical antipsychotic such as mean doses of RIS (3.1±1.9mg/day), of OLZ (5.1±3.2mg/day), and of QET (60.0±37.3mg/day) was added on ongoing SSRI(Paroxetine, Fluvoxamine).
Behavioral: exposure response prevention
After at least 12 weeks from treatment initiation, cognitive-behavioral therapy (CBT) using exposure and response prevention was added with psychoeducational interventions and behavioral analysis.

Detailed Description:

More recently, second-generation atypical antipsychotic drugs (AAPD) that modulate both 5-HT and DA function, such as risperidone (RIS), olanzapine (OLZ) and quetiapine (QET), have been found effective in the augmentation of SSRIs for treatment-resistant OCD.

Nevertheless, the AAPDs have been associated with common and serious adverse effects, such as body weight (BW) gain and metabolic dysregulation. Metabolic dysregulation includes glucoregulatory dysfunction and dyslipidemia. Indeed, studies of some AAPD in SSRI-refractory OCD patients have similarly reported significant BW gain. AAPD-induced BW gain may influence patients' adherence to medication and places them at risk for a broad range of medical problems.

Most work on AAPDs in treatment-refractory OCD has been conducted in the form of short-term efficacy studies. There have been fewer studies of the effectiveness, safety, and tolerability of these agents in the context of a clinic where CBT is also provided, and where treatment is continued for a significant period of time. In the current effectiveness study, we sought to examine the response of SSRI-refractory patients to augmentation with AAPDs, comparing adverse events in such compared to a control group of SSRI responders.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 years of age or over
  • Patients were diagnosed as having obsessive-compulsive disorder by the Structured Clinical Interview for DSM-IV Patient version (SCID-P)
  • They received standardized treatment for at least 1 year at the OCD clinic in our university hospital.
  • Each subject gave written informed consent to take part after receiving a complete description of this study.
  • All subjects were free of medical illness based on results of physical examination and screening tests of blood and urine, and no subjects received any lipid lowering or hypoglycemic agent during the 1-year study period.

Exclusion Criteria:

  • Current clinically significant medical conditions such as diabetes
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00854919

Locations
Japan
Dept of Neuropsychiatry, Osaka City University, graduate School of Medicine
Osaka, Japan, 545-8585
Sponsors and Collaborators
Osaka City University
  More Information

No publications provided by Osaka City University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00854919     History of Changes
Other Study ID Numbers: 18591305
Study First Received: March 2, 2009
Last Updated: March 2, 2009
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Osaka City University:
obsessive-compulsive disorder
augmentation treatment
SSRI-refractory

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Disease
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014